Caffeine vs. ALA in BMS Treatment. (BMS: Burning Mouth Syndrome. ALA: Alpha-Lipoic Acid.)

Caffeine Clinical Trial

Official title:

Efficacy of Caffeine vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06195137
• Other study ID #: WCHSIRB-D-2021-407
• Status: Completed
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: June 23, 2023

Study information

• Verified date: December 2023
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the efficacy of caffeine and alpha-lipoic acid in the treatment of burning mouth syndrome by symptom assessment with visual analogue scale.

Description:

The etiology of BMS is multifactorial, involving a complex interplay of neuropathic, psychological, neuroendocrine, and immunological factors. Neurologically, BMS has been categorized into three subtypes: peripheral small fiber neuropathy, subclinical trigeminal neuropathy, and inhibitory dopaminergic deficiency. Neuroimaging and peripheral nerve studies have further implicated altered brain activation patterns and increased expression of specific receptors like TRPV1 and P2X3 in the pathogenesis of BMS. Hormonal imbalances, particularly in estrogen levels, have also been suggested to contribute to contribute to the condition. Caffeine, a xanthine alkaloid chemically known as 1,3,7-trimethylxanthine, is recognized for its diverse biological functions. As a central nervous system stimulant, its primary mechanism involves antagonizing adenosine receptors, thereby enhancing the release of neurotransmitters such as dopamine and norepinephrine, which are known to play roles in analgesic pathways. Caffeine is also noted for its neuroprotective properties and is theorized to reduce the risk of neurodegenerative diseases. It affects the central processing of pain and is involved in regulating circadian rhythms and sleep-wake cycles. Additionally, caffeine has mild anti-inflammatory properties. Its stimulatory effects may also improve mood and cognitive function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 23, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults over 18 years of age
• Diagnosis of BMS according to the 3rd edition of the International Classification of Headache Disorders (ICHD-3)
• Daily intraoral burning or dysaesthesia lasting for more than 2 hours for over 3 months
• Normal oral mucosa and sensory testing
• Condition not better accounted for by another ICHD-3 diagnosis

Exclusion Criteria:

1. Secondary BMS due to local or systemic disorders

2. Prior treatment for BMS

3. Psychiatric or progressive neurological disorders

4. Systemic disorders potentially associated with oral disease

5. Long-term history of smoking, drinking, or medication use

6. Consumption of caffeinated products

7. Poor oral hygiene

8. Abnormal blood test results (including blood count, glucose, serum iron, ferritin and transferrin, folic acid, or vitamin B12 levels)

9. Incomplete medical records

10. Unwillingness to participate

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Caffeine
• Syndrome

Intervention

Dietary Supplement:
• Caffeine
caffeine supplementation

Drug:
• Alpha Lipoic Acid
600-800 mg ALA

Locations

Country	Name	City	State
China	West China Hospital of Stomatology, Sichuan University	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Lu Jiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	During the interview or telephone follow-up with the patient, ask the patient to fill in the VAS rating scale.	Baseline and 2 weeks after intervention or observation